A) Field of the Invention
This invention relates to a method of distribution of pills and a pill having a machine readable code.
B) Description of Related Art
Pills are packaged in containers, from single-pill containers to containers that contain thousands of pills. Pills encompass, for instance, tablets, caplets, gel-caps, and capsules, and contain either medication or a placebo. Pills come in a variety of shapes, sizes and colors to help distinguish one from the other.
Aside from possibly serving as an enticement for children, the configuration (shape, size, and color) of pills generally does not give one supplier or manufacturer a competitive edge over another due to the appeal of the particular configuration in the marketplace. If the pills of different suppliers contain different medicine, there is no reason for them to have the same configuration. If they did, one pill could easily be mistaken for the another, potentially leading to disastrous consequences.
If the pills of different suppliers contain the same medication, it makes sense for safety reasons to standardize the configuration to avoid the potential for mix-up in the event of switching between brands. Such a mix-up may lead to severe health risks and could be lethal.
On the other hand, a brand name may lose market share to a newcomer that merely copies the same pill configuration and, in a sense, passes it off as being an equivalent if not identical to the brand name version. The company owning the brand name may have spent years developing and promoting the outward appearance or product configuration of its pills to establish good will and may be unable to stop the newcomer from flooding the market with a cheaper, but identical version to capture market share. If sued for wrongful misappropriation of product configuration, the newcomer may successfully assert that for public health and safety reasons, the configurations should be the same to avoid consumer mix-up between pills containing different medications. In effect, the successful newcomer is permitted easier access to gain market share, because of the ability to profit from the consumer feeling comfortable switching brands due to the familiar configuration of the pills that the consumer was accustomed to with the brand name. Indeed, the newcomer's pill may provide the same impression of quality and efficacy as the brand name.
When a product shipped to one distributor finds its way to the territory of some other distributor in violation of the trademark rights of that other distributor, the product traveling in this manner is considered to be gray goods. The distributor who has trademark rights for the territory into which the gray goods travel may sue to stop such shipment of product between territories.
One difficulty, however, lies in determining the origin of the goods, particularly if the goods themselves are not marked in such as way as to distinguish them from one trademark territory to another. This has often been the case with pills. A problem is that although a package containing pills may include a territorial designation code, the pill itself is not assigned such a code and may therefore be easily repackaged to hide its channel of distribution. The absence of such a code fails to assist in the identification of the distributor licensee that was responsible.
Often pill containers are properly marked and sealed so that the manufacturing source can be identified by lot number. Since the container is sealed, one would expect that the pills inside the container match the lot number on the container. Regrettably, as the cost of medication rises, the temptation grows for merchants or suppliers to substitute some or all of the pills of the container with a cheaper generic version, seal the container, and pass it off as containing the pills from the original name brand. It is likely that the consumer will not suspect the switch, although may notice that the medication is less effective than expected. Regardless, the merchant profits handsomely. The manufacturer of the brand name product, however, in effect loses a sale and, worse, loses some of its good will as the consumer wrongfully blames the brand name manufacturer for the poor quality over which the manufacturer had no control. If the consumer suffers medically from the switched medication, the integrity of the brand name is damaged. In addition, the consumer did not get the brand name product for which he or she paid a premium. This problem arose because the consumer has no way of checking whether the pills in the container are the proper pills made by the labeled manufacturer.
Some medical institutions handle huge volumes of pills each day. Their employees go through the daily ritual of sorting the pills and dispensing them to the appropriate patients in accordance with each patient's specific dosage schedule. Mistakes do happen and pills get mixed up, particularly if they resemble each other in appearance. Any improperly administered medication can, of course, be life threatening to a patient. If generic versions are being used, then even the level of identification often afforded by brand name logo on the pill is absent. This problem arises because the pills may not have markings on them to correctly apprise staff of their medical content. If there is any question as to the content of a pill in the hospital environment, the pill is simply discarded. The cost of such discarded pills can only add to the ever increasing cost of medical care and insurance.
During clinical trials that test for efficacy of new medication, a select group of patients are given active medication, while another group take a placebo pill. It is preferred that these tests be conducted as single-blind or double-blind tests wherein even the doctor who administers the medication is not told which pills are active and which are placebo. However, as the doctor divides the medication consistently between the two groups, recording which patient receives which pill (as each pill is marked with a letter, number, or color code), the content of the pills for each patient becomes apparent to the doctor by observing the health of each particular patient during the trial. A doctor, following the Hippocratic Oath of medicine, may compromise the clinical trial by giving all the patients only those pills that the doctor perceives to contain the active medication. Also, the patients themselves may assess which pills are placebo and which are active by comparing the markings on the pills with the apparent effectiveness of the particular pill. Eventually, the test taker may become uncooperative and refuse to take any pill with markings that indicate a placebo, arguing that his or her health warrants taking real medication. The reliability of the clinical trial diminishes if an insufficient number of tests are conducted with the placebo.
These problems in clinical testing may lead to delays in gaining government drug regulatory approval. The problem may be especially acute with life sustaining drugs or cures for otherwise fatal diseases, because patients will become uncooperative when they know that only a placebo is being given. Here, of course, the problem is that the pills are marked in such a manner that the human eye can readily distinguish between them.
A Pharmacist generally fills all the prescriptions of a customer and thus should know the customer's medical history, which medication the customer may take and is currently taking. If a new prescription comes in, the Pharmacist is supposed to check for contra-indications regarding other medication currently prescribed to the customer. Unfortunately, the pills do not have warnings on them to let the Pharmacist know that filling the particular prescription may be dangerous if the customer is already on certain kinds of medication. Too much responsibility is placed on the Pharmacist and invariably mistakes are made, leading to life threatening consequences. The problem here is that no markings are provided either on the pill or container that the Pharmacist could readily check to avoid prescribing medically dangerous combinations of medications. In some cases, the Pharmacist has access to a computer having a software program designed to remind the Pharmacist of potential interactions of a particular drug. To activate the program, the Pharmacist must type in the National Drug Code pertaining to the particular drug or its drug name into the computer. This relatively simple task may sometimes be ignored or misused by Pharmacists.
Once a pill leaves its container, it becomes impossible to check its efficacy expiration date, its medication contents, etc. unless the container remains accessible. If the container is emptied and lost or otherwise discarded, unused pills will be unidentifiable, particularly if the pill lacks any brand name identification. It may be dangerous to take such a pill, depending upon the person's particular medical condition and the expiration date. The problem arises due to a lack of information on the pill itself.
The current distribution system requires that pills destined for off-the-shelf sales be packaged in their own sealed container to guard against tampering and contamination. The packaging is sized to contain a certain number of pills, from single-pill packaging, to bulk-size containers. This arrangement is necessary because pills are not marked in a manner that would permit the pills to be sorted from others at the place of purchase or dispensement. Only the containers are adequately marked to avoid confusion. Thus, the consumer has little choice in selecting the quantity of medication to purchase.
Persons whose vision is impaired or are blind are most susceptible to mixing up pills if different kinds of pills have the same feel and taste and such persons do not seek the assistance of others who can see. Such persons would find it beneficial to a device or system that assists in distinguishing between pills by relying upon their other senses, in particular, their hearing.
Keeping track of the efficacy of pills is a labor intensive task, requiring the patient or care giver to manually record when a pill is taken and when its effects wear off. Since the recording process is labor intensive, it is subject to human error and errors in recording the proper time. Nutrition may affect the efficacy of medication and recording information on nutrition is also a labor intensive task. Once the record is made, to be of lasting value, it must be stored in a data base. This requires some further manual effort in converting the manual entries from a journal into data entries into the computer.
Micro bar code is known. It is about one tenth the size of standard (MF=1) UPC bar code (Magnification Factor (MF)=1). Scanners for reading micro bar code are available commercially, such as from Neorex Corporation in Japan and Symbol Technologies, Inc. of Holtsville, New York. Symbol Technologies, Inc. has developed a 2D, high density bar code called PDF-417 and a corresponding scanner. The PDF-417 code is considered a high-density code capable of containing more information per area than standard UPC code.
It would be desirable to identify the source, distributor, medication contents and/or potency expiration date of a pill after the pill is dispensed, preferably through a scanner of machine readable code. Where identification of the code by reading it directly with the unaided eye poses a problem, it is preferred that the patterns within the code be too small to be resolved by an unaided eye.